SHS_300313 BERR CKEY 16128
A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
The Keystone Heart TriGuard device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the study is to assess the safety and efficacy of the TriGuard embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected transcatheter aortic valve implantation (TAVI).
Select Inclusion Criteria:
Male or non-pregnant female ≥18 years of age
Meets indications for transcatheter aortic valve implantation (TAVI)
Willing to comply with protocol-specified follow-up evaluations
Select Exclusion Criteria:
Undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
Undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
Known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure .
History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months
Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
History of a stroke or transient ischemic attack (TIA) within the prior 12 months.
Renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min)
Hepatic failure (Child-Pugh class C)
Hypercoagulable states that cannot be corrected by additional periprocedural heparin
Presenting with cardiogenic shock at the time of the index procedure.
Severe peripheral arterial disease that precludes delivery sheath vascular access
Aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous.
Contraindication to cerebral magnetic resonance imaging (MRI).
Planned treatment with any other investigational device or procedure during the study period.
Planned to undergo any other cardiac surgical or interventional procedure during the transcatheter aortic valve implantation (TAVI) procedure or within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the transcatheter aortic valve implantation (TAVI) procedure.
Heart and Vascular,
Robert Bersin, M.D.